Article Figures & Data
Figures
- Figure 1. OPTIMISE-HFpEF programme of research
HFpEF = heart failure with preserved ejection fraction. WP = work package.
- Figure 2. Flow of participants
HFpEF = heart failure with preserved ejection fraction. WP = work package.
Tables
MRC complex intervention stage mapping WP1 De scription Systematic review of disease management programmes tested in HFpEF populations (see Prospero: CRD42017067980). Identifying the evidence base. Loc ation Cambridge, UK Recruitment N/A Data collection Commenced October 2017 – completed September 2019 WP2a Des cription Qualitative interview study to determine patient and health professionals’ preferences, perspectives on burden of illness and treatment, care requirements, and organisation of services and/or support in HFpEF. Identifying and/or developing theory.Modelling process and outcomes. Loc ation Collaborative, multi-site study involving Cambridge, Keele, and Manchester (UK). Sites are utilising the NIHR Primary Care Research Network to identify general practices in their region through which recruitment of patients and primary care clinicians will be managed. Secondary and primary care-based HFS services will be approached to augment recruitment. Other healthcare providers and commissioners will be identified via local networks. Rec ruitment Commenced October 2017 – planned end March 2020 Data collection Data collection involves face-to-face or telephone interview with patients ±their carers and healthcare professionals managing or structuring care for patients with HFpEF, including but not limited to HFS nurses, cardiologists, GPs, practice nurses, healthcare commissioners, and rehabilitation specialists. WP2b Des cription Prospective longitudinal observational cohort study that will identify probable HFpEF patients, confirm HFpEF status, characterise the cohort at baseline, and prospectively follow-up confirmed HFpEF cases for 1 year. Modelling process and outcomes.Estimate recruitment and retention.Determine sample sizePreliminary testing of procedures. Loc ation Collaborative, multi-site study involving the Universities of Cambridge and Oxford, and Cardiology/Care of the Elderly services at North West Anglia and Guy’s and St. Thomas’ NHS Foundation Trust. Cambridge and Oxford will utilise the NIHR Primary Care Research Network to identify general practices in their region through which recruitment of patients will be managed. Rec ruitment Commenced July 2018 – planned end July 2020. Data collection Data collection involves a baseline visit where a diagnostic echocardiogram will be performed (previously performed diagnostic echocardiograms will be used at secondary care sites) to confirm the presence or absence of HFpEF. Additional assessments at baseline are described in Table 2. WP2c Des cription Qualitative interview sub-study employing a framework analysis approach to explore hospitalisation in HFpEF patients, transitions of care, and their carers’ perspectives. Identifying and/or developing theory.Modelling process and outcomes. Loc ation Sub-study within the Cambridge longitudinal cohort sample. Rec ruitment Commenced December 2018 – planned end July 2020. Data collection Data collection involves face-to-face interviews with patients and their carers. Basic demographic information and interview notes and/or reflections will also be collected. WP3 Des cription Summary statement and questions presented to stakeholders to gauge consensus, explore disparity, identify sticking points, and elicit programme refinements. Identifying and/or developing theory.Modelling process and outcomes.Preliminary testing of procedures.Understanding change process. Location UK-wide, diverse sample of non-collocated 'experts' with various levels and domains of expertise (including but not limited to: patients, primary care physicians, cardiologists, echocardiography specialists, HFS, and heart failure charities). Rec ruitment Commenced April 2019 – planned end December 2020. Data collection Using a structured online system, the experts will be asked to discuss the summary statement. Comments are aggregated, then quantitatively and qualitatively analysed using statistical modelling techniques to enable decision-making based on the input from the expert panellists. PROSPERO is the international prospective register of systematic reviews, accessible at https://www.crd.york.ac.uk/prospero/
HFpEF = heart failure with preserved ejection fraction. HFS = heart failure specialist. MRC = Medical Research Council. N/A = not applicable. NIHR = National Institute for Health Research. WP = work package.
Parameter Measure Description Physical characteristics Anthrop Height in centimetres, weight in kilograms, BMI kg/m2 Vitals Blood pressure (mmHg) Respiratory rate (breaths per minute) Pulse rate (beats per minute) Past medical history N/A Past and current medical problems and medications will be extracted from primary and secondary care records Clinical events HES Hospital Episode Statistics (date, length of time and index reason for hospitalisations, accident and emergency attendances, and outpatient appointments) Heart function ECG 12-lead ECG Echo Detailed echocardiogram with high-quality diastolic and right ventricle functional assessment Arterial stiffness a PWV A validated reproducible technique to investigate the clinical relevance of vascular and arterial stiffness36 Peripheral oedema N/A Clinical assessment of oedema including level (extent) and presence or absence of pitting Breathlessness and fatigue mBORG Valid, reliable measure of the intensity of the sensation of breathlessness and fatigue37 Frailty CFS A validated measure of frailty based on clinical judgment38 SHARE-FI A validated automated instrument that generates a pre-calculated, population-representative, and sex-specific frailty class39 eFI eFI uses routine medical record data to identify older people with mild, moderate, and severe frailty and will be abstracted from primary care records40 Comorbidity CCI Widely used validated measure of 1-year mortality risk and burden of disease41 Cognition MoCA The MoCA is a brief cognitive screening tool with high sensitivity and specificity for detecting mild cognitive impairment42 Physical functioning and activity 6MWT A standardised submaximal test of aerobic capacity, validated in multiple populations and conditions43 GS Gait speed measured over 10 metres, a valid objective measure of functional mobility44 Acceler Objective measure of activity obtained via Axivity AX3 wrist-worn triaxial accelerometer programmed to start at 19:00 hours on the day of the baseline visit (to prevent capturing of protocol forced activity) and capture triaxial acceleration data over a 7-day period at 100 Hz with a dynamic range of +–8 g45 Laboratory testing Biochem Serum sodium, potassium, creatinine, urea, estimated GFR, random plasma glucose Haem White and red blood cell count, haemoglobin, haematocrit, mean cell volume, mean cell haemoglobin, red cell distribution width, platelet count, mean platelet volume, neutrophil, lymphocyte, monocyte, eosinophil, basophil count Biomarkers HbA1c An indicator of the average blood glucose concentrations over the preceding ~2 months. NP Natriuretic peptides (NT-proBNP), a diagnostic marker in patients with heart failure Dietary intake a Interview One 24-hour dietary recalled will be collected to ascertain over or undernutrition in HFpEF patients Anxiety and depression HADS HADS is a widely used questionnaire that screens for the separate dimensions of anxiety and depression and has been validated in multiple populations32 HF QoL KCCQ KCCQ is a valid, reliable and responsive health status measure for patients with chronic heart failure that has been shown to have clinically meaningful changes33 HF self-care EHFScBQ A valid, reliable and practical scale to measure the self-reported self-care behaviour of heart failure patients.34 HF symptoms SSQ-HF Valid and reliable score to assess physical symptoms in patients with heart failure.35 Health-related QoL EQ-5D The EQ-5D is a widely used five-domain patient-based generic questionnaire for self-perceived health assessment. It describes health-related quality of life and has been extensively validated. 6MWT = 6-minute walk test. Acceler = accelerometry. Anthrop = anthropometry. Biochem = biochemistry. BMI = body mass index. CCI = Charlson comorbidity index. CFS = clinical frailty scale. ECG = electrocardiogram. Echo = echocardiogram. eFI = electronic frailty index. eGFR = estimated glomular filtration rate. EHFScBQ = European heart failure self-care behaviours questionnaire. EQ-5D = the EuroQol 5D questionnaire. GS = gait speed. HADS = hospital anxiety and depression score. Haem = haematology. HbA1c = glycated haemoglobin A1c. HES = hospital episode statistics. KCCQ = Kansas City cardiomyopathy questionnaire. mBORG = modified BORG. MoCA = Montreal cognitive assessment. N/A = not applicable. NP = natriuretic peptides. PWV = pulse wave velocity. QoL = quality of life. SHARE-FI = SHARE frailty instrument. SSQ-HF = symptom status questionnaire — heart failure.
aIndicates single site sub-study.
Supplementary Data
SUPPLEMENTARY DATA
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Supplementary material is not copyedited or typeset, and is published as supplied by the author(s). The author(s) retain(s) responsibility for its accuracy.
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Optimising Management of Patients with Heart Failure with Preserved Ejection Fraction in Primary Care (OPTIMISE-HFpEF): rationale and protocol for a multi-method study
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